Evidence map›Paper›PMID 30823880›Full record

Trial reportRespiratory research2019

Psychometric properties and minimal important differences of SF-36 in Idiopathic Pulmonary Fibrosis.

Sabine Witt, Ekaterina Krauss, María Asunción Nieto Barbero, Veronika Müller, Philippe Bonniaud, Carlo Vancheri, Athol U Wells, Martina Vasakova, Alberto Pesci, Walter Klepetko and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Respiratory research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02951416 (The European IPF Registry - an Internet-based, Pan-European Registry Linked to the European IPF Biobank), which is not on this map. Cited by 33 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 6 pooled it
5.4field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02951416 active not recruitingnot on this map

The European IPF Registry - an Internet-based, Pan-European Registry Linked to the European IPF Biobank (eurIPFbank)

Typeobservational_patient_registrySponsorAndreas GuentherRan2009 to 2040Enrolled2,000ConditionsIdiopathic Pulmonary Fibrosis, Idiopathic Interstitial Pneumonia, Interstitial Lung Diseases, Diffuse Parenchymal Lung DiseasesArmspatient registry (observation and biomaterial sampling)
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 6 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
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  5. Pooled it
  6. Health-related quality of life of patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2020
    Pooled it
  7. Trial
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  13. Review
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  18. Serum Krebs von den Lungen-6: promising biomarker to differentiate CPFE from IPF.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2022
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  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 8 countries.

Sabine WittHelmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research (DZL), Comprehensive Pneumology Center Munich (CPC-M), Neuherberg, Germany. sabine.witt@helmholtz-muenchen.de.
Ekaterina KraussEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
María Asunción Nieto BarberoEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Veronika MüllerEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Philippe BonniaudEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Carlo VancheriEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Athol U WellsEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Martina VasakovaEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Alberto PesciEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Walter KlepetkoEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Werner SeegerEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Bruno CrestaniEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
Reiner LeidlHelmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research (DZL), Comprehensive Pneumology Center Munich (CPC-M), Neuherberg, Germany.
Rolf HolleHelmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research (DZL), Comprehensive Pneumology Center Munich (CPC-M), Neuherberg, Germany.
Larissa SchwarzkopfHelmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research (DZL), Comprehensive Pneumology Center Munich (CPC-M), Neuherberg, Germany.
Andreas GuentherEuropean IPF Registry & Biobank (eurIPFreg/bank), Giessen, Germany.
European Central Bank · DEGerman Center for Lung Research · DEHelmholtz Zentrum München · DEAzienda Ospedaliera San Gerardo · ITCardio-Pulmonary Institute · DECHU Dijon Bourgogne · FRHôpital Bichat-Claude-Bernard · FRSemmelweis University · HUUniversity of Catania · ITVienna General Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIdiopathic pulmonary fibrosis (IPF) is a rare disease with a median survival of 3-5 years after diagnosis with limited treatment options. The aim of this study is to assess the psychometric characteristics of the Short Form 36 Health Status Questionnaire (SF-36) in IPF and to provide disease specific minimally important differences (MID).

methodsData source was the European IPF Registry (eurIPFreg). The psychometric properties of the SF-36 version 2 were evaluated based on objective clinical measures as well as subjective perception. We analysed acceptance, feasibility, discrimination ability, construct and criterion validity, responsiveness and test-retest-reliability. MIDs were estimated via distribution and anchor-based approaches.

resultsThe study population included 258 individuals (73.3% male; mean age 67.3 years, SD 10.7). Of them 75.2% (194 individuals) had no missing item. The distribution of several items was skewed, although floor effect was acceptable. Physical component score (PCS) correlated significantly and moderately with several anchors, whereas the correlations of mental component score (MCS) and anchors were only small. The tests showed mainly significant lower HRQL in individuals with long-term oxygen therapy. Analyses in stable individuals did not show significant changes of HRQL except for one dimension and anchor. Individuals with relevant changes of the health status based on the anchors had significant changes in all SF-36 dimensions and summary scales except for the dimension PAIN. PCS and MCS had mean MIDs of five and six, respectively. Mean MIDs of the dimensions ranged from seven to 21.

conclusionIt seems that the SF-36 is a valid instrument to measure HRQL in IPF and so can be used in RCTs or individual monitoring of disease. Nevertheless, the additional evaluation of longitudinal aspects and MIDs can be recommended to further analyse these factors. Our findings have a great potential impact on the evaluation of IPF patients.

trial registrationThe eurIPFreg and eurIPFbank are listed in https://clinicaltrials.gov ( NCT02951416 ).

Indexed as

Health StatusAgedCross-Sectional StudiesFemaleFollow-Up StudiesHumansIdiopathic Pulmonary FibrosisLongitudinal StudiesMaleMiddle AgedPsychometricsReproducibility of ResultsSurveys and QuestionnairesIdiopathic pulmonary fibrosisPatient-reported outcomeQuality of lifeRare diseases

Identifiers

PMID30823880
PMCPMC6397447
OpenAlexW2926243537

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.